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510(k) K854882

PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT by Lee Pharmaceuticals — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1986
Date Received
December 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Pit And Fissure, And Conditioner
Device Class
Class II
Regulation Number
872.3765
Review Panel
DE
Submission Type

Other clearances by Lee Pharmaceuticals

  • K924378 — RESTOBOND 4 (March 31, 1993)
  • K912256 — PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT (July 24, 1991)
  • K900809 — LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS (June 28, 1990)
  • K894315 — RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT (October 31, 1989)
  • K881903 — PROSTHODENT VL (July 1, 1988)
  • K873123 — LEE COMPOSITE INLAY SYSTEM (January 20, 1988)
  • K863157 — RESTODENT POSTERIOR (September 25, 1986)
  • K844133 — CLEANSE N BOND I (January 4, 1985)
  • K844134 — CLEANSE N BOND II (January 4, 1985)
  • K843363 — RESTODENT VL (October 25, 1984)

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  • K230455 — Enamel Coating Resin (July 25, 2023)
  • K190998 — BA Pit & Fissure Sealant (November 8, 2019)
  • K190339 — Helioseal F Plus (July 29, 2019)
  • K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP (January 5, 2018)
  • K171330 — Nanova Sealant (September 8, 2017)
  • K162598 — HAPI Seal (May 23, 2017)
  • K161580 — Premier Sealant (October 18, 2016)
  • K141717 — PACSEAL PIT & FISSURE SEALANT (March 9, 2015)